BRISBANE, Calif., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients today reported it has received a Paragraph IV Certification Notice Letter (PIV Notice) from The WhiteOak Group, a subsidiary of a small private Chinese company. WhiteOak has filed an Abbreviated New Drug Application, or ANDA, with the FDA for a product claiming... Read more
Epioxa Provides the Ophthalmic Community and Patients with the First and Only FDA-Approved, Incision-Free, Topical Drug Therapy for Keratoconus
Epioxa Represents a Novel, Groundbreaking Therapy for Patients Afflicted by This Sight-Threatening Rare Disease
Epioxa Expected to Be Commercially Available in Q1 2026 ALISO VIEJO, Calif. / Oct 20, 2025 / Business Wire / Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on... Read more
Once-daily Precision Timed Release™ (PTR™) stimulant designed to deliver rapid onset of effect and entire active-day duration
NDA accepted under the FDA’s 505(b)(2) regulatory pathway KANSAS CITY, Kan., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform,... Read more
Key Points Immuron submits Investigational new drug (IND) application to FDA for clinical development of IMM-529 as product to specifically prevent or treat Clostridioides difficile infection (CDI)
Previous clinical trial data on IMM-529 provides support for continued development of IMM-529 MELBOURNE, Australia, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), is pleased to announce that it has submitted an Investigational New Drug (IND)... Read more
The DECLARATION (safety and efficacy vs. placebo) and LIBERTY (exploratory safety head-to-head and combination with mRNA-based COVID vaccination) clinical trials are expected to begin around year-end 2025; top-line data anticipated mid-2026
DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate prevention of COVID, at three months, from a single intramuscular (IM) dose of VYD2311, with longer-term protection anticipated. A second VYD2311... Read more
Disc is seeking accelerated approval and priority review of its NDA submission
FDA decision to accept and file the NDA for review occurs within 60 days of submission WATERTOWN, Mass., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced the submission of... Read more
KETAFREE™ to provide innovative, preservative-free IV ketamine formulation, eliminating toxic preservatives, in keeping with current HHS priorities to eliminate toxic preservatives from foods and drugs
Filing is based on FDA interaction and approval of Suitability Petition for NRx’s proposed strength of preservative-free ketamine
This presentation of ketamine represents a reshoring of a strategically important drug to the US, in keeping with the Presidential Executive... Read more
RAPT on track to initiate trial this year SOUTH SAN FRANCISCO, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared RAPT’s Investigational New Drug (IND) Application... Read more
Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's disease spectrum
Positive results across all three Phase 3 TEMPO trials reinforce the potential of tavapadon, a novel selective dopamine D1/D5 receptor partial agonist, in Parkinson's disease
If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option NORTH... Read more
Calgary, Alberta--(Newsfile Corp. - September 23, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), the leading autologous (patient's own) stem cell therapy company offering VesCell™ (ACP-01) to no-option individuals suffering from peripheral arterial disease, chronic limb threatening ischemia, angina, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia, in Florida under Florida's SB 1768, is pleased... Read more
Regulatory submissions filed in the U.S., UK, Europe, Serbia and Australia
Three-month randomized placebo-controlled study to assess safety, pharmacokinetics, dose, muscle biopsies, and measures of function in ambulatory children
First patient expected to be enrolled into the study by the end of 2025
Long-term extension study approved in Australia with adult patients from the Phase 1b trial; additional adult patients also planned
Company also provides financial update... Read more
FDA assigns a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026 REDWOOD CITY, Calif. / Sep 10, 2025 / Business Wire / Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the U.S. Food and Drug Administration (FDA) has accepted Corcept’s... Read more
There are currently no approved vaccines or treatments for norovirus infection
Cocrystal’s CDI-988 is the first antiviral for the potential prevention and treatment of viral gastroenteritis caused by norovirus infections
Phase 1b study is expected to start by year-end 2025 BOTHELL, Wash., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that the Company received a Study May Proceed Letter... Read more
If approved, ZORYVE cream would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2, offering patients and caregivers an important alternative to topical steroids and vitamin-D analogs
ZORYVE cream is uniquely formulated to be effective, safe, and well tolerated for all areas of the body, including sensitive areas such as intertriginous skin, where plaque psoriasis often presents in children WESTLAKE VILLAGE, Calif.,... Read more
Filing based on pivotal Phase 3 ORCA-2 and ORCA-3 clinical trials demonstrating statistically significant and clinically meaningful smoking cessation
FDA acceptance starts the review process and sets timing for potentially the first new FDA-approved pharmacotherapy in two decades
PDUFA targeted date set for June 20, 2026 SEATTLE and VANCOUVER, British Columbia, Sept. 03, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty... Read more
Dosing of first patient in Phase 1 dose escalation trial of IDE892 targeted in 4Q 2025
Preclinical profile of IDE892 and mechanistic combination rationale with IDE397, IDEAYA's proprietary MAT2A inhibitor, will be presented at the 10-Year Anniversary R&D Day on September 8th SOUTH SAN FRANCISCO, Calif., Sept. 3, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, announced the submission of an investigational... Read more
FDA Establishes April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH)
Comprehensive Data Package Supported by Positive Results from Phase 3 STRIVE-ON Safety Trial of GTx-104 PRINCETON, N.J., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a... Read more
New Drug Application (NDA) for low-dose contrast agent gadoquatrane seeks approval for contrast-enhanced magnetic resonance imaging (MRI) of the central nervous system (CNS) and other body regions for adults and pediatric patients including neonates
Submitted dose corresponds to a 60 percent reduction in gadolinium compared to macrocyclic gadolinium-based contrast agents (GBCAs) dosed at 0.1 mmol gadolinium per kilogram of body weight WHIPPANY, N.J. / Aug 27, 2025 /... Read more
FDA acceptance enables initiation of a Phase 2 multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS HOUSTON, Aug. 25, 2025 /PRNewswire/ -- Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announces that the... Read more
SL-325 is a potentially first-in-class DR3 antagonist antibody being developed for the treatment of Inflammatory Bowel Disease (IBD) and other inflammatory and immune-mediated diseases
The Company is on track to dose the first participant in its Phase 1 SL-325 clinical trial in healthy volunteers in Q3 2025
Current cash and cash equivalents, plus the anticipated aggregate proceeds of up to $103 million from recent private placement, assuming full exercise of common... Read more
U.S. Food and Drug Administration accepts sNDA for filing with priority review; sets PDUFA goal date of December 20, 2025
European Medicines Agency accepts and validates submission for Type II variation MAA for setmelanotide to treat acquired hypothalamic obesity
Company to host “Commercial Readiness for Acquired Hypothalamic Obesity,” event for investors and analysts on Wednesday, September 24, in Boston BOSTON, Aug. 20, 2025 (GLOBE NEWSWIRE)... Read more
INDs Transferred from Statera Biopharma Advance Entolimod for ARS Along Regulatory Pathway and Enable Pursuit of Clinical Trial Program in Neutropenia and Lymphocyte Exhaustion FREMONT, Calif. / Aug 20, 2025 / Business Wire / Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, today announced it has received, from Statera Biopharma, two investigational new drug applications (INDs) for its lead candidate, Entolimod™. The two INDs cover... Read more
NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, is pleased to announce that the U.S. Food & Drug Administration (FDA) have approved the IND for its Phase 2a clinical trial of intranasal foralumab in patients with Multiple... Read more
Filing based on pivotal Phase 3 VERITAC-2 clinical trial demonstrating statistically significant and clinically meaningful improvement in median progression-free survival versus fulvestrant
Vepdegestrant is the first PROteolysis TArgeting Chimera (PROTAC) to demonstrate clinical benefit in patients with breast cancer NEW HAVEN, Conn., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today with its partner Pfizer Inc. (NYSE: PFE), announced... Read more
Regulatory filing marks significant milestone for medication designed to provide once-daily, entire active-day symptom control in ADHD patients KANSAS CITY, Kan., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced that it has submitted... Read more
Novel combination therapy with STAR-001 targets the most aggressive and deadliest forms of brain cancer at first progression
GBM represents an annual market opportunity of $3 to $5 billion USD with an accelerating number of cases globally
Lantern Pharma has previously received both FDA Orphan and Fast Track Designations in GBM DALLAS / Aug 06, 2025 / Business Wire / Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma Inc. (NASDAQ: LTRN), today announced... Read more
Designed to expand PSMA PET imaging access for patients by increasing batch size by ~50% and enhancing supply resilience
PDUFA date set for March 6, 2026 BEDFORD, Mass., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that the Food and Drug Administration... Read more
CID-103 is a potential best-in-class, anti-CD38 monoclonal antibody; binds to unique CD38 epitope Phase 1 study in adults with active and chronic active renal allograft AMR planned to initiate AMR is a leading cause of kidney transplant loss, leading to dialysis and/or repeat renal transplant SAN FRANCISCO, CA / ACCESS Newswire / August 4, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing... Read more
Progress Follows Positive Immune Response Observed in Phase 1 Study SAN JOSE, Calif., Aug. 4, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that, in collaboration with Cleveland Clinic, it has initiated the transfer of the Investigational New Drug (IND) application that supported the Phase 1 clinical trial of its breast cancer v... Read more
Combination therapy has potential to be an all-oral, fixed-duration regimen for previously untreated patients with CLL
Application is supported by data from the Phase 3 AMPLIFY trial that showed statistically significant improvement in progression-free survival vs chemoimmunotherapy
Regimen offers an opportunity for patients to take time off treatment, an important step toward improved disease management NORTH CHICAGO, Ill., July 29, 2025 /PRNewswire/ -- AbbVie... Read more
